The research work was carried out for establishing a new Ultra Violet (UV)— Visible spectroscopy and Reverse phase-Ultra Fast Liquid Chromatography (RP-UFLC) method for the analysis and quantification of a biosimilar...The research work was carried out for establishing a new Ultra Violet (UV)— Visible spectroscopy and Reverse phase-Ultra Fast Liquid Chromatography (RP-UFLC) method for the analysis and quantification of a biosimilar drug, Filgrastim. Filgrastim or recombinant methionyl granulocyte colony stimulating factor (rGCSF) is a glycoprotein. It has a biological action essential for proliferation and differentiation of hematopoetic and progenitor cells. The UV and RP-UFLC work was carried on a Shimadzu UV1800 Spectrophotometer and Shimadzu Prominence LC-20AD UFLC systems, respectively. The <i>λ</i><sub>max</sub> of filgrastim was found to be 215 nm. The correlation coefficient by UV spectroscopy was found to be 0.9994 for the concentration range of 1 to 3 μg/ml in double distilled water. The Reverse phase UFLC was done by using Phenomenex C4 (25 cm × 0.46 cm internal diameter) 15 μ, 300 A° analytical column. The optimized mobile phase for binary elution was Acetonitrile and double distilled water (80:20) with a flow rate of 1 ml/min. The retention time of drug was at 3.2 min. It was observed that the response of the detector was linear in the range of 5 - 15 μg/ml with correlation coefficient value of 0.999. After developing the methods, it was assured for the intended use by validation of the analytical parameters like linearity, accuracy, precision, limit of detection, limit of quantitation, ruggedness and robustness. The results of all the parameters for both the methods were found to be within the acceptance criteria as per the International Council for Harmonisation (ICH) guidelines.展开更多
Spectroscopy is a perfect analyzer to find the elements of all matter. The application of spectroscopy has been used to interpret the effect of antibiotics and other medicines after its life duration. This has been st...Spectroscopy is a perfect analyzer to find the elements of all matter. The application of spectroscopy has been used to interpret the effect of antibiotics and other medicines after its life duration. This has been studied by using the diabetics tablet melmet, expired for an year, to visualize the changes physically and chemically [1-3]. It has been observed that the occurrence of changes in color and reduction of smell and also the formation of new peaks and shift by XRD and UV, FTIR characterization respectively [4].展开更多
目的研究新型芳基异丙酸类化合物2-[4-(3-氧代丁基)苯基]丙酸(OPPA)与牛血清白蛋白(BSA)的相互作用。方法利用瞬态/稳态荧光光谱法和紫外光谱法,测算结合常数、结合位点数、热力学参数和分子的结合距离。结果在25℃下,反应平衡常数为3.9...目的研究新型芳基异丙酸类化合物2-[4-(3-氧代丁基)苯基]丙酸(OPPA)与牛血清白蛋白(BSA)的相互作用。方法利用瞬态/稳态荧光光谱法和紫外光谱法,测算结合常数、结合位点数、热力学参数和分子的结合距离。结果在25℃下,反应平衡常数为3.9×104L·mol-1,结合位点数为0.8;焓变为-16.29 k J·mol-1,熵变为205.04 J·mol-1·K-1,吉布斯自由能为-26.21 k J·mol-1;OPPA与BSA分子中色氨酸的最近距离为3.26 nm。结论 OPPA与BSA的相互作用为动态猝灭和静态猝灭的协同机理,OPPA与BSA的相互作用力主要是疏水相互作用力和静电作用力相互作用。展开更多
文摘The research work was carried out for establishing a new Ultra Violet (UV)— Visible spectroscopy and Reverse phase-Ultra Fast Liquid Chromatography (RP-UFLC) method for the analysis and quantification of a biosimilar drug, Filgrastim. Filgrastim or recombinant methionyl granulocyte colony stimulating factor (rGCSF) is a glycoprotein. It has a biological action essential for proliferation and differentiation of hematopoetic and progenitor cells. The UV and RP-UFLC work was carried on a Shimadzu UV1800 Spectrophotometer and Shimadzu Prominence LC-20AD UFLC systems, respectively. The <i>λ</i><sub>max</sub> of filgrastim was found to be 215 nm. The correlation coefficient by UV spectroscopy was found to be 0.9994 for the concentration range of 1 to 3 μg/ml in double distilled water. The Reverse phase UFLC was done by using Phenomenex C4 (25 cm × 0.46 cm internal diameter) 15 μ, 300 A° analytical column. The optimized mobile phase for binary elution was Acetonitrile and double distilled water (80:20) with a flow rate of 1 ml/min. The retention time of drug was at 3.2 min. It was observed that the response of the detector was linear in the range of 5 - 15 μg/ml with correlation coefficient value of 0.999. After developing the methods, it was assured for the intended use by validation of the analytical parameters like linearity, accuracy, precision, limit of detection, limit of quantitation, ruggedness and robustness. The results of all the parameters for both the methods were found to be within the acceptance criteria as per the International Council for Harmonisation (ICH) guidelines.
文摘Spectroscopy is a perfect analyzer to find the elements of all matter. The application of spectroscopy has been used to interpret the effect of antibiotics and other medicines after its life duration. This has been studied by using the diabetics tablet melmet, expired for an year, to visualize the changes physically and chemically [1-3]. It has been observed that the occurrence of changes in color and reduction of smell and also the formation of new peaks and shift by XRD and UV, FTIR characterization respectively [4].
文摘目的研究新型芳基异丙酸类化合物2-[4-(3-氧代丁基)苯基]丙酸(OPPA)与牛血清白蛋白(BSA)的相互作用。方法利用瞬态/稳态荧光光谱法和紫外光谱法,测算结合常数、结合位点数、热力学参数和分子的结合距离。结果在25℃下,反应平衡常数为3.9×104L·mol-1,结合位点数为0.8;焓变为-16.29 k J·mol-1,熵变为205.04 J·mol-1·K-1,吉布斯自由能为-26.21 k J·mol-1;OPPA与BSA分子中色氨酸的最近距离为3.26 nm。结论 OPPA与BSA的相互作用为动态猝灭和静态猝灭的协同机理,OPPA与BSA的相互作用力主要是疏水相互作用力和静电作用力相互作用。